FDA Inspection
Rotech Home Medical Care, Inc.Rotech Home Medical Care, Inc. – FDA Inspection, Mar 30, 2012
Record Details
This FDA Inspection record concerns Rotech Home Medical Care, Inc., with an inspection on March 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 30, 2012
- Product Type
- Drugs
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ID · 7f31c0c0-53ea-483f-86b1-d42b4032d66d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774772
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.165(e)Test methods
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